Vestibular DiseaseMUPIDNCT04241822
Musculoskeletal Pain in Long-term Dizziness
A study testing Vestibular exercises combined with body awareness exercises and cognitive therapy and Exergaming in people with Vestibular Disease and Musculoskeletal Pain, run by Western Norway University of Applied Sciences at 1 site in Norway.
Trial summary
This project is aimed at patients with dizziness believed to be due to conditions in the balance organ in the inner ear (vestibular diseases). Dizziness can be bothersome and influence postural control negatively, and can cause secondary musculoskeletal disorders. Dizziness can also result in reduced work capacity. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Vestibular Disease, Musculoskeletal Pain, Rehabilitation
- What is being tested?
- Vestibular exercises combined with body awareness exercises and cognitive therapy and Exergaming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteNorway
- Study dates
- 15 Aug 2020to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients referred to an otorhinolaryngological university clinic due to suspected vestibular disorders (dizziness)
- Patients must be bothered with dizziness at the time of consultation
Who cannot join
- Patients uable to fill in questionnaires due language barriers
- Patients not able to undergo diagnostic and testing procedures
- Patients with vestibular Schwannoma
- Patients with diving-related inner ear injuries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Musculoskeletal Pain in Long-term Dizziness- Incidence, Prognosis and Measures
This project is aimed at patients with dizziness believed to be due to conditions in the balance organ in the inner ear (vestibular diseases). Dizziness can be bothersome and influence postural control negatively, and can cause secondary musculoskeletal disorders. Dizziness can also result in reduced work capacity. The purpose of the project is to strengthen the knowledge base regarding symptom burden, prognosis and treatment of prolonged dizziness. The hypothesis is that musculoskeletal pain at baseline is a prognostic factor for prolonged dizziness.
Read the detailed description
Patients referred to an tertiary otorhinolarynglogical clinic due to dizziness will be invited to participate in the study. The aims are to examine the prevalence, extent and distribution of musculoskeletal pain in patients with prolonged dizziness, and to investigate the associations between musculoskeletal pain, dizziness symptoms, psychological and physical function and health-related quality of life.
Furthermore, the aim is to monitor the natural course of the dizziness symptoms and functional status in these patients, and examine risk factors for prolonged disability after 6 and 12 months. The hypothesis is that muscle pain and distress at baseline may be independently associated with prolonged complaints at follow-up.
Finally, patients who still are dizzy and have pain after 12 months will be invited to participate in one of two group interventions a) modified vestibular rehabilitation and b) virtual reality / exergaming. The interventions will be feasibility studies with a pre-post design.
- Conditions
- Vestibular Disease, Musculoskeletal Pain, Rehabilitation
- Being tested
- Vestibular exercises combined with body awareness exercises and cognitive therapy, Exergaming
- Keywords
- vestibular disease, musculoskeletal pain, prognosis, vestibular rehabilitation
- Medical subject headings
- Vestibular Diseases, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular exercises combined with body awareness exercises and cognitive therapyBehavioural
The intervention is group based and is a combination of information/education, vestibular exercises (head movements and gaze stability exercises) body awareness exercises and cognitive therapy
ExergamingBehavioural
The intervention consists of different balance exercises using non-immersive virtual reality
| Study group | Role | What they receive |
|---|---|---|
| Vestibular exercises combined with cognitive therapy | Experimental | The intervention is in groups of 8-10 patients. The interventions consists of cognitive therapy, vestibular exercises and body awareness therapy, 8 group sessions Receives: Behavioral: Vestibular exercises combined with body awareness exercises and cognitive therapy |
| Exergaming | Experimental | The intervention is individual and consist of non-immersive virtual reality exercises to improve balance Receives: Behavioral: Exergaming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dizziness Handicap Inventory. 0-100 (high score worst)
Baseline status and change in dizziness handicap
Measured: Baseline, 26 weeks, 1 year, through study completion, an average 18 months
Secondary outcomes (10)
Nordic Pain Questionnaire. 0-10 (high score worst)
Baseline status and change in musculoskeletal pain
Measured: Baseline, 26 weeks, 1 year, through study completion, an average 18 months
Vertigo Symptom Scale. 0-60 (high score worst)
Baseline status and change in vertigo symptoms
Measured: Baseline, 26 weeks, 1 year, through study completion, an average 18 months
RAND-12 health related quality of life. 0-60 (high score better)
Baseline status and change in health related quality of life
Measured: Baseline, 26 weeks, 1 year
Hospital Anxiety and Depression Scale. 0-42 (high score worst)
Baseline status and change in anxiety and depression symptoms
Measured: Baseline, 26 weeks, 1 year
Dizziness Catastrophising Scale. 0-52 (high score worst)
Baseline status and change in catastrophising thoughts about the dizziness
Measured: Baseline, 26 weeks, 1 year, through study completion, an average 18 months
Posturography. Body sway while standing on a force platform.
Baseline status and change after intervention
Measured: Baseline,1 year, through study completion, an average 18 months
Four tests of Body flexibility derived from the Global Physiotherapy Examination- 52
Baseline status and change after intervention
Measured: Baseline,1 year, through study completion, an average 18 months
Walking test preferred speed, 6 m (m/s)
Baseline status and change after intervention
Measured: Baseline,1 year, through study completion, an average 18 months
Walking test fast speed, 6 m (m/s)
Baseline status and change after intervention
Measured: Baseline,1 year, through study completion, an average 18 months
Grip Strength
Baseline
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start15 Aug 2020
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- After 1 year participants who still have dizziness complaints will be offered one of two interventions: 1. Group-based vestibular rehabilitation combining cognitive intervention, vestiular exercises and body awareness therapy 2. Exergaming intervention with virtual reality exercises using data games and videos, and other balance exercises.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Norway University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital
- Responsible party
- Principal investigator, Liv Heide Magnussen, Western Norway University of Applied Sciences
- Investigators
- Gro Anita F Flaten, ph.d., Study director, Western Norway University of Applied SciencesEvelyn Neppelberg, ph.d., Study director, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241822
- Sponsor's protocol ID
- 6849
- Acronym
- MUPID
- Status last verified
- Aug 2024
- First submitted
- 15 Jan 2020
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musculoskeletal Pain in Long-term Dizziness- Incidence, Prognosis and Measures
- ClinicalTrials.gov ID
- NCT04241822
- Acronym / sponsor ID
- MUPID / 6849
- Conditions
- Vestibular Disease, Musculoskeletal Pain, Rehabilitation
- Keywords
- vestibular disease, musculoskeletal pain, prognosis, vestibular rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Western Norway University of Applied SciencesUniversity, hospital or other
- Collaborators
- Haukeland University Hospital
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project is aimed at patients with dizziness believed to be due to conditions in the balance organ in the inner ear (vestibular diseases). Dizziness can be bothersome and influence postural control negatively, and can cause secondary musculoskeletal disorders. Dizziness can also result in reduced work capacity. The purpose of the project is to strengthen the knowledge base regarding symptom burden, prognosis and treatment of prolonged dizziness. The hypothesis is that musculoskeletal pain at baseline is a prognostic factor for prolonged dizziness.
Detailed description
Patients referred to an tertiary otorhinolarynglogical clinic due to dizziness will be invited to participate in the study. The aims are to examine the prevalence, extent and distribution of musculoskeletal pain in patients with prolonged dizziness, and to investigate the associations between musculoskeletal pain, dizziness symptoms, psychological and physical function and health-related quality of life.
Furthermore, the aim is to monitor the natural course of the dizziness symptoms and functional status in these patients, and examine risk factors for prolonged disability after 6 and 12 months. The hypothesis is that muscle pain and distress at baseline may be independently associated with prolonged complaints at follow-up.
Finally, patients who still are dizzy and have pain after 12 months will be invited to participate in one of two group interventions a) modified vestibular rehabilitation and b) virtual reality / exergaming. The interventions will be feasibility studies with a pre-post design.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After 1 year participants who still have dizziness complaints will be offered one of two interventions: 1. Group-based vestibular rehabilitation combining cognitive intervention, vestiular exercises and body awareness therapy 2. Exergaming intervention with virtual reality exercises using data games and videos, and other balance exercises.
| Arm | Type | Receives |
|---|---|---|
| Vestibular exercises combined with cognitive therapy | Experimental | Behavioral: Vestibular exercises combined with body awareness exercises and cognitive therapyThe intervention is in groups of 8-10 patients. The interventions consists of cognitive therapy, vestibular exercises and body awareness therapy, 8 group sessions |
| Exergaming | Experimental | Behavioral: ExergamingThe intervention is individual and consist of non-immersive virtual reality exercises to improve balance |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients referred to an otorhinolaryngological university clinic due to suspected vestibular disorders (dizziness)
- Patients must be bothered with dizziness at the time of consultation
Key exclusion criteria (4 listed)
- Patients uable to fill in questionnaires due language barriers
- Patients not able to undergo diagnostic and testing procedures
- Patients with vestibular Schwannoma
- Patients with diving-related inner ear injuries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vestibular exercises combined with body awareness exercises and cognitive therapyThe intervention is group based and is a combination of information/education, vestibular exercises (head movements and gaze stability exercises) body awareness exercises and cognitive therapy | Behavioural | Vestibular exercises combined with cognitive therapy |
| ExergamingThe intervention consists of different balance exercises using non-immersive virtual reality | Behavioural | Exergaming |
Primary outcome
Dizziness Handicap Inventory. 0-100 (high score worst)
Time frame: Baseline, 26 weeks, 1 year, through study completion, an average 18 months
Baseline status and change in dizziness handicap
10 secondary outcomes
Nordic Pain Questionnaire. 0-10 (high score worst)
Time frame: Baseline, 26 weeks, 1 year, through study completion, an average 18 months
Vertigo Symptom Scale. 0-60 (high score worst)
Time frame: Baseline, 26 weeks, 1 year, through study completion, an average 18 months
RAND-12 health related quality of life. 0-60 (high score better)
Time frame: Baseline, 26 weeks, 1 year
Hospital Anxiety and Depression Scale. 0-42 (high score worst)
Time frame: Baseline, 26 weeks, 1 year
Dizziness Catastrophising Scale. 0-52 (high score worst)
Time frame: Baseline, 26 weeks, 1 year, through study completion, an average 18 months
Posturography. Body sway while standing on a force platform.
Time frame: Baseline,1 year, through study completion, an average 18 months
Four tests of Body flexibility derived from the Global Physiotherapy Examination- 52
Time frame: Baseline,1 year, through study completion, an average 18 months
Walking test preferred speed, 6 m (m/s)
Time frame: Baseline,1 year, through study completion, an average 18 months
Walking test fast speed, 6 m (m/s)
Time frame: Baseline,1 year, through study completion, an average 18 months
Grip Strength
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
Related trials for Vestibular Disease
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Comparison of Vestibular Stimulation and Core Stability Training on Sitting Balance in Hypotonic CP
Hypotonic Cerebral Palsy
Enrolling by invitationObservational study
Long Term Follow-up Study of AAVAnc80-antiVEGF Gene Therapy
Vestibular Schwannoma
RecruitingPhase 1/2
Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma
Vestibular Schwannoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gro Anita F Flaten, ph.d. study director
Western Norway University of Applied Sciences
Evelyn Neppelberg, ph.d. study director
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular exercises combined with body awareness exercises and cognitive therapy and Exergaming in people with Vestibular Disease and Musculoskeletal Pain, run by Western Norway University of Applied Sciences at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dizziness Handicap Inventory. 0-100 (high score worst) (time frame: Baseline, 26 weeks, 1 year, through study completion, an average 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.